Analytical Scientist, 4581576

Artech Information System LLC; East Hanover (NJ); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading IT Staffing Company in New Jersey is seeking a Quality Control Analyst responsible for routine QC Stability testing and analytical data verification. Candidates must possess at least 3 years of experience in a cGMP laboratory and a degree in analytical chemistry. Proficiency in HPLC, GC, and other analytical tools is essential. This role demands excellent organizational and communication skills, adhering to FDA and cGMP regulations while ensuring good documentation practices.

Qualifications

• Minimum of 3 years' experience in a cGMP laboratory.
• Knowledge of stability regulation and its application in the industry.
• Familiarity with FDA, DEA, and EPA regulations.
• Ability to follow good documentation practices.

Responsibilities

• Perform routine QC Stability testing of finished dosage forms.
• Verify and validate US CPO Quality Control data.
• Ensure compliance with established QC procedures.
• Independently troubleshoot analytical and instrument problems.

Skills

cGMP laboratory experience

HPLC

GC

UV/VIS

Dissolution testing

Excellent communication

Excellent organizational skills

Analytical data interpretation

Education

Degree in analytical chemistry

Tools

LIMS

Job description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

Job Description

Responsible for performing routine QC Stability testing of finished dosage forms and complaint samples.

Experience with HPLC, GC, UV/VIS, Dissolution and other typical QC Analytical instrumentation is required.

Verifies / validates US CPO Quality Control data, while monitoring for trends and abnormalities. Reports and acts on data results.

Responsible to ensure that established QC procedures are followed.

Responsible for following laboratory schedules (as applicable).

Responsible to ensure good documentation practices are followed.

Responsible for serving on various project teams to fulfill activities as assigned.

Individual is capable of independently troubleshooting analytical and instrument problems.

Individual is responsible for assuring adherence to Federal (FDA, DEA, EPA), OSHA regulations, cGMP's, SOP's, company policies and procedures.

The individual will comply with Good Manufacturing Practices, Health, Safety and Environmental policies and other federal regulations and company policies and procedures.

Skills:

A minimum of 3 years’ experience working in a cGMP laboratory is required.

Knowledge of stability regulation and its application to the industry.

Knowledge of cGMPs. (ICH Guidelines)

Excellent organizational, communication and leadership skills are required.

Excellent interpersonal skills including use of tact, diplomacy, discretion and judgement.

Interpretation/Analytical data

The candidate must possess a positive attitude, be flexible/adaptable and able to practice team building and demonstrate good positive people skills.

LIMS (Laboratory Information Management) ERP systems preferred.

Qualifications

A degree in analytical chemistry is preferred.